Method and device for insertion of orthopedic fixation pin with blind hole

ABSTRACT

A fixation device is disclosed including an elongate body extending from a distal end to a proximal end. The distal end defines a blind hole having a diameter and extending to a depth from a distal tip. The diameter of the blind hole is sufficient to receive a k-wire therein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/946,269 filed Nov. 15, 2010, which claims priority to U.S.provisional patent application No. 61/261,928 filed on Nov. 17, 2009,the entirety of which are incorporated herein by reference.

SUMMARY

A fixation device is disclosed including an elongate body extending froma distal end to a proximal end. The distal end defines a blind holehaving a diameter and extending to a depth from a distal tip. Thediameter of the blind hole is sufficient to receive a k-wire.

A method is also disclosed in which a k-wire is inserted into a bonesuch that a portion of the k-wire extends from a surface of the bone. Afixation device that defines a blind hole is slid over a portion of thek-wire that extends from a surface of the bone. The fixation device isdriven into the bone along an axis defined by the k-wire. A bottom wallof the fixation device contacts an end of the k-wire as the fixationdevice is driven into the bone. The k-wire is removed from the bone.

The foregoing and other aspects will be apparent from the followingdescription of the preferred embodiments. In the description, referenceis made to the accompanying drawings which form a part hereof, and inwhich there is shown by way of illustration, and not limitation, apreferred embodiment. Such embodiment does not necessarily represent thefull scope of the invention, and reference must therefore be made to theclaims herein for interpreting the scope of the invention and itsequivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bemore fully disclosed in, or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which are tobe considered together with the accompanying drawings wherein likenumbers refer to like parts and further wherein:

FIG. 1 is a side view of one example of a fixation device;

FIG. 2 is a detailed side view of a portion of the fixation device shownin FIG. 1;

FIG. 3 is an isometric view of the fixation device illustrated in FIG.1;

FIG. 4 is a detail view of the distal end of the fixation device shownin FIG. 3;

FIG. 5 is an isometric view of another example of a fixation device;

FIG. 6 is a sectional view of the fixation device taken along line 6-6in FIG. 5;

FIG. 7 illustrates a k-wire being inserted into a neck of a talus;

FIG. 8 illustrates a k-wire inserted into the neck of the talus;

FIG. 9 illustrates a blind hole of a fixation device being aligned withan end of the k-wire inserted through the neck of the talus;

FIG. 10 illustrates a fixation device inserted over an end of the k-wireinserted through the neck of the talus.

FIG. 11 illustrates a fixation device inserted through a neck of thetalus;

FIG. 12 illustrates a distal end of the fixation device being cut by asurgical tool;

FIG. 13 illustrates the fixation device installed through the neck ofthe talus;

FIG. 14 illustrates a fixation device being installed across a subtalarjoint;

FIG. 15 illustrates a fixation device being installed across a fibulaand a tibial platform to fuse a fracture of the tibial plateau;

FIG. 16 illustrates a fixation device being installed across a fibulaand a base of a tibia to fuse a fracture at the base of a tibia;

FIG. 17 is a medial view of a Charcot foot;

FIG. 18 illustrates the metatarsal axes along which k-wires areinstalled for a foot beaming operation; and

FIG. 19 illustrates a fixation device installed in the Charcot foot torepair the mid-foot arch.

DETAILED DESCRIPTION

This description of preferred embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. The drawing figures are notnecessarily to scale and certain features of the invention may be shownexaggerated in scale or in somewhat schematic form in the interest ofclarity and conciseness. In the description, relative terms such as“horizontal,” “vertical,” “up,” “down,” “top,” and “bottom” as well asderivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,”etc.) should be construed to refer to the orientation as then describedor as shown in the drawing figure under discussion. These relative termsare for convenience of description and normally are not intended torequire a particular orientation. Terms including “inwardly” versus“outwardly,” “longitudinal” versus “lateral,” and the like are to beinterpreted relative to one another or relative to an axis ofelongation, or an axis or center of rotation, as appropriate. Termsconcerning attachments, coupling, and the like, such as “connected” and“interconnected,” refer to a relationship wherein structures are securedor attached to one another either directly or indirectly throughintervening structures, as well as both movable or rigid attachments orrelationships, unless expressly described otherwise. The term“operatively connected” is such an attachment, coupling or connectionthat allows the pertinent structures to operate as intended by virtue ofthat relationship.

FIGS. 1-4 illustrate one example of an improved fixation device 100. Thefixation device 100 may be a transfixion pin, a half-pin for coupling toother components of an external fixator, a traction pin, or the like. Asshown in FIG. 1, fixation device 100 includes an elongate body 102having a distal end 104 and a proximal end 106. Proximal end 106 of thefixation device may include an engagement feature 108 for engagementwith a driving device. Threads 110 may be optionally disposed along aportion of a length of fixation device 100 between distal end 104 andproximal end 106.

Engagement feature 108 of proximal end 106 may take a variety of forms.As best seen in FIG. 3, engagement feature 108 includes a plurality offlats 112 formed on an exterior surface 114 of elongate body 102 so asto provide a gripping surface for a driving device. As will beunderstood by one skilled in the art, the number of flats 112 onexterior surface 114 of proximal end 106 may be varied such thatproximal end 106 may have a variety of cross-sectional geometriesincluding, but not limited to, triangular, square, pentagonal,hexagonal, to name a few. In some embodiments, engagement feature 108formed at proximal end 106 of fixation device 100 may be a socket-typeengagement feature such as, for example, a hex socket for receiving ahex key. Other examples of other socket-type engagement featuresinclude, but are not limited to, a Phillips socket, a Torx socket, aSpanner head, a poly-drive, or the like.

As best seen in FIGS. 2 and 3, distal end 104 of fixation device 100defines a blind hole 116 having a side wall 118 and a bottom wall 120.Blind hole 116 may be formed such that it is concentric with an outerdiameter of elongate body 102 and extends along a central axis definedby elongate body 102. Blind hole 116 may have a diameter that issufficiently large to receive a k-wire. The engagement between blindhole 116 and the k-wire may be a slip-fit engagement. In someembodiments, blind hole 116 has a diameter between approximately 1 mm(approximately 0.04 inches) to approximately 3 mm (approximately 0.12inches). One skilled in the art will understand that the diameter ofblind hole 116 may be adjusted to accommodate k-wires of differentdiameters. In some embodiments, blind hole 116 may extend to a depth ofapproximately 2.5 cm (approximately 1 inch) and 5 cm (approximately 2inches). The depth of blind hole 116, i.e., the distance from a distaltip 122 of the fixation device 100 to bottom wall 120, may be vary.However, in some embodiments an overly shallow depth, e.g., less than 1mm, may cause some difficulty for the user to engage and align thek-wire with blind hole 116. In contrast, overly deep depth of blind hole116 may result in side and bottom walls 118, 120 of blind hole 116 beingdifficult to sterilize as well as reducing the strength of fixationdevice 100.

Distal end 104 may also include a cutting feature 124 for drilling andsecuring fixation device 100 into a bone. For example, distal end 104may include threads, a fluted shank, or another feature to aide in theinsertion of fixation device 100 into bone. In FIG. 4, distal end 104 ofthe fixation device 100 is shown with a fluted shank 126, which mayinclude one or more helical grooves 128 defined by body 102 of fixationdevice 100 to form a twist drill as will be understood by one skilled inthe art. Distal tip 122 of fixation device 100 may also include a taper130 to aide in the placement of fixation device 100 within bone asillustrated in FIG. 2.

Threads 110 may be disposed at various positions along the length ofelongate body 102 of fixation device 100 for engaging bone to maintainthe position of fixation device 100 in bone. In one embodiment, threads110 are disposed approximately halfway between distal end 104 andproximal end 106 and may be sufficiently long to extend beyond eitherside of the bone into which fixation device 100 is located.

Fixation device 100 may also include a cutting guide 132 disposed alonga length of body 102 for identifying a location at which blind hole 116ends. In some embodiments, cutting guide 132 is a line etched into anouter surface 134 of fixation device 100 and is disposed adjacent tofluted shank 126, as seen in FIGS. 1 and 2. Cutting guide 132 may be aline that completely, or partially, encircles elongate body 102 offixation device 100. One skilled in the art will understand that cuttingguide 132 may take a variety of other forms including, but not limitedto, a crimp, a bump, texturing, coloring, or the like.

Bone Screw

FIGS. 5-6 illustrate one example of an improved fixation device 200configured as a bone screw. As shown in FIG. 5, fixation device 200includes a completely or partially threaded elongate body 202 having adistal end 204 and a proximal end 206. Proximal end 206 may have anenlarged diameter forming a head 208, which defines an engagementfeature 210. For example, head 208 may define an engagement socket 210configured to engage a driving tool such as, for example, a Phillipsscrewdriver, a hex or Allan key, a Torx driver, or the like for drivingfixation device 200 into bone as described below.

Distal end 204 of bone screw 200 defines a blind hole 212 having a sidewall 214 extending from a distal tip 216 to a bottom wall 218 as bestseen in FIG. 6. The depth of blind hole 212 may be approximately 2.5 cm(approximately 1 inch) to approximately 5 cm (approximately 2 inches)although one skilled in the art will understand that the depth of blindhole 212 may be vary. Distal tip 216 may include a taper 220 to aide inthe insertion of fixation device 200 in bone.

Threads 222 may extend along an exterior surface 224 of elongate body202 from distal tip 216 towards proximal end 206. However, one skilledin the art will understand that threads 222 may be disposed at variouspositions along the elongate body.

The fixation devices 100, 200 described above may be fabricated from anymedical grade material including, but not limited to, stainless steel,titanium, a cobalt chrome alloy, to name a few. Additionally, thefixation devices may be provided a wide-range of sizes and styles aswill be understood by one skilled in the art.

Surgical Procedures

I. Installation of External Fixation Pin in Neck of Talus

FIGS. 7-13 illustrate a fixation device 100 in the form of a fixationpin being inserted into a neck of a talus 400. As shown in FIGS. 7 and8, a k-wire 300 may be inserted through a neck 402 of talus 400. Asurgeon may check the alignment of k-wire 300 in talus 400 usingfluoroscopy as will be understood by one skilled in the art. If thesurgeon determines that k-wire 300 is not properly aligned, then k-wire300 may be removed and repositioned within talus 400. Fluoroscopy mayagain be used to check the alignment of the k-wire 300.

Once k-wire 300 is positioned in talus 400, a fixation pin 100 maysecured in neck 402 of talus 400. To secure fixation pin 100 in talus400, blind hole 116 of fixation pin 100 is aligned with an end 302 ofk-wire 300 (FIG. 9). Blind hole 116 is then slid over end 302 of k-wire300 until distal tip 122 is brought into engagement with a surface 404of talus 400 (FIG. 10). K-wire 300 may be positioned within talus 400such that end 302 that is received within blind hole 116 of fixation pin100 does not contact bottom wall 120 of blind hole 116 when distal tip122 of fixation pin 100 contacts surface 404 of talus 400.

The surgeon may use a tool, such as a Jacobs chuck or other device (notshown) for engaging engagement feature 108 of fixation pin 100, to drivefixation pin 100 into neck 402 of talus 400. For example, the surgeonmay use the driving device to rotate fixation pin 100 causing flutedshank 126 of fixation pin 100 to cut into talus 400. As fixation device100 advances into talus 400, bottom wall 120 of blind hole 116 contactsend 302 of k-wire 300 resulting in k-wire 300 being driven along withfixation pin 100 into talus 400. The surgeon continues to drive fixationpin 100 into talus 400 until k-wire 300 is forced from the opposite sideof talus 400 (FIG. 11). In some procedures, the surgeon may continue todrive fixation pin 100 into talus 400 until one to two inches ofelongate body 102 of fixation pin 100 are exposed on either side oftalus 400. If fixation pin 100 includes threads 110 disposed along thelength of body 102, then the surgeon may continue to drive fixation pin100 into talus 400 until a portion of threads 110 are visible on eitherside of talus 400.

With the fixation pin 100 secured in neck 402 of talus 400, the surgeonmay locate cutting guide 132 disposed along the length of fixation pin100 and cut fixation pin 100 to a desired length (FIG. 12). For example,the surgeon may cut fixation pin 100 with cutters 500 such that flutedshank 126 and blind hole 116 at distal end 104 are removed to leave asolid fixation pin 100 disposed within talus 400 (FIG. 13). The surgeonmay attach additional devices for maintaining the position of the ankleto fixation pin 100 as will be understood by one skilled in the art.

II. Installation of Bone Screw For Subtalar Fusion

The use of a bone screw fixation device 200 for fusing of subtalar joint410 between a talus 400 and a calcaneus 450 is illustrated in FIG. 14.An ankle of a patient may be opened and a k-wire 300 inserted through aninferior portion of calcaneus 450 through talus 400. A surgeon may checkthe position of k-wire 300 in calcaneus 450 and talus 400 usingfluoroscopy and reposition the k-wire 300 as desired. Once the desiredpositioning of k-wire 300 in calcaneus 450 and talus 400 is achieved,the surgeon may slide blind hole 212 disposed at distal end 204 of bonescrew 200 over an end 302 of k-wire 300 until distal tip 216 of bonescrew 200 contacts a surface 452 of calcaneus 450. As described above,k-wire 300 may extend from calcaneus 450 such that end 302 of k-wire 300does not contact bottom wall 218 of blind hole 212 when distal tip 216of bone screw 200 contacts surface 452 of calcaneus 450.

The surgeon may then use a driving tool such as an Allan key, Torxdriver, screwdriver or other device configured to engage engagementfeature 210 disposed on proximal end 206 of bone screw 200 to drive bonescrew 200 into calcaneus 450, across subtalar joint 410, and into talus400. Threads 222 disposed along elongate body 202 of bone screw 200 maygrip talus 400, calcaneus 450, or both talus 400 and calcaneus 450 tofuse subtalar joint 410. K-wire 300 may then be removed when bone screw200 is secured in calcaneus 450 and talus 400.

III. Installation of Bone Screw For Plateau Facture of Tibia

FIG. 15 illustrates a bone screw fixation device 200 for correcting afracture of a tibial plateau 600. A k-wire 300 may be inserted throughfibula 700, bone segment 604, tibia 600, and bone segment 602. Once thesurgeon is satisfied with the position of k-wire 300 in fibula 700,tibia 600, and bone segments 602, 604, a bone screw 200 is selected andblind hole 212 is slid over an end k-wire 300 until distal tip 216 ofbone screw 200 contacts a surface 702 of fibula 700. As described above,k-wire 300 may extend from fibula 700 such that an end 302 of the k-wire300 does not contact bottom wall 218 of blind hole 212 when distal tip216 of bone screw 200 contacts surface 702 of fibula 700.

The surgeon may then drive bone screw 200 into fibula 700, first bonesegment 604, tibia 600, and into second tibial bone segment 602 by usinga tool such as an Allan key, Torx driver, or other device configured toengage engagement features 210-1, 210-2 disposed on proximal ends 206-1,206-2 of bone screws 200-1, 200-2. K-wires 300 may be removed whenthreads 222-1, 222-2 of bone screws 200-1, 200-2 are secured in fibula700, tibia 600 and bone segments 602, 604. Heads 208-1, 208-2 of bonescrews 200-1, 200-2 retain bone segments 602, 604 against tibia 600 topromote fusion of the fractures.

IV. Installation of Bone Screw For Pilon Fracture of Tibia

FIG. 16 illustrates a pair of bone screw fixation devices 200-1, 200-2to correct a pilon fracture. A k-wire (not shown) may be insertedthrough a first tibial bone segment 606 and into the base of tibia 600along the line A shown in FIG. 16. A second k-wire may be insertedthrough a second tibial bone segment 608 and into the base of tibia 600.Fewer or more k-wires may be used depending on the number of bonefragments as will be understood by one skilled in the art. A surgeon maycheck the position of the k-wires using fluoroscopy and reposition thek-wires until the desired position of the k-wires has been achieved aswill be understood by one skilled in the art.

Blind holes 212-1, 212-2 of bone screw fixation devices 200-1, 200-2 maybe inserted over the respective k-wires. The surgeon may secure bonesegments 606, 608 to tibia 600 by driving bone screws 200-1, 200-2 intotibia 600. As bone screws 200-1, 200-2 are driven into the tibia, bottomwalls 218-1, 218-2 of blind holes 212-1, 212-2 contact the ends of thek-wires forcing the k-wires in the direction of travel of the bone screwwith which it is in contact. Bone screws 200-1, 200-2 may driven intotibia 600 until distal tip 216-1, 216-2 of each bone screw is close to asurface of tibia 600 and head 208-1, 208-2 of the bone screw contacts asurface of bone segment 606, 608 that the screw is securing to tibia600. With bone screws 200-1, 200-2 secured to the tibia, the k-wires maybe removed from tibia 600 by pulling the k-wires along theintramedullary channel that they formed by being inserted into tibia600.

V. Charcot Foot

Fixation devices 100, 200 may also be used in a beaming surgicalprocedure to correct a collapsed arch such as a Charcot foot. FIG. 17illustrates a Charcot foot 800 having a collapsed arch as shown by lineC. K-wires may be installed along the axes defined by the metatarsals asindicated by the lines D and E in FIG. 18. Bone screw fixation devicesmay then be inserted over k-wires 300 through metatarsals 802,cuneiforms 804, navicular 806, and into talus 400 to restore the arch ofthe mid-foot. A surgeon may check the positioning of the k-wires usingfluoroscopy as will be understood by one skilled in the art.

When the desired positioning of the k-wires has been achieved, thesurgeon may insert each bone screw 200 through the metatarsal 802,cuneiform 804, navicular 806, and into talus 400 using the k-wires as aguide. As described above, a blind hole 212 of a bone screw 200 is slidover a k-wire 300, which is used to guide the installation of the bonescrew fixation device 200. A surgeon drives bone screw 200 into placeusing a tool configured to engage engagement feature 210 disposed on theproximal end of bone screw 200.

As the surgeon drives bone screw 200 along an axis of metatarsal 802,bottom wall 218 of blind hole 212 of bone screw 200 contacts an end ofk-wire 300 and forces the k-wire along the axis of metatarsal 802. Bonescrew 200 is driven along the axis of metatarsal 802 until head 208 ofthe bone screw contacts a surface of metatarsal 802. FIG. 19 illustratesa bone screw 200 installed through the metatarsal 802, cuneiform 804,navicular 806, and secured in talus 400. As shown in FIG. 19, fixationdevices 200 restore the arch of the mid-foot as identified by line F.

The fixation devices described herein may also be used in a variety ofother surgical procedures in which the extension of a k-wire through abone or tissue will not cause damage to an artery or tissue as will beunderstood by one skilled in the art. Advantageously, the fixationdevices described herein provide enhanced strength over conventionalhollow fixation devices along with enhanced safety as they do notinclude through holes enabling fluid to flow into a body of a patient.Additionally, the fixation devices disclosed herein do not require holesfor the fixation devices to be drilled into bone or sealing the centralhole as do conventional hollow fixation devices.

Although the invention has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodimentsof the invention, which may be made by those skilled in the art withoutdeparting from the scope and range of equivalents of the invention.

What is claimed is:
 1. A fixation device, comprising: an elongate bodyextending from a distal end to a proximal end, the distal end defining ablind hole having a diameter and extending to a depth from a distal tip,the diameter of the blind hole sufficient to receive a k-wire therein, alength of the elongate body being threaded, and a head disposed at theproximal end of the elongate body, the head having a diameter greaterthan an external diameter of the elongate body.
 2. The fixation deviceof claim 1, wherein the depth that the blind hole extends from thedistal end is greater than a length that the threaded portion extendsfrom the distal end.
 3. The fixation device of claim 1, wherein the headdefines an engagement feature.
 4. The fixation device of claim 3,wherein the engagement feature is configured to engage a driving toolselected from the group consisting of a screwdriver, a hex key, and aTorx driver.
 5. The fixation device of claim 1, wherein the depth of theblind hole is between approximately 2.5 cm and approximately 5.0 cm. 6.The fixation device of claim 1, wherein the distal end includes a taper.7. A method, comprising: inserting a k-wire into a bone such that aportion of the k-wire extends from a surface of the bone; sliding ablind hole of a fixation device over a portion of the k-wire thatextends from a surface of the bone; driving the fixation device into thebone along an axis defined by the k-wire, a bottom wall of the blindhole contacting an end of the k-wire as the fixation device is driveninto the bone; and removing the k-wire from the blind hole.
 8. Themethod of claim 7, wherein the fixation device includes an elongate bodyextending from a distal end to a proximal end, the distal end definingthe blind hole extending to a depth from a distal tip.
 9. The method ofclaim 8, wherein the distal end includes a fluted shank extending fromthe distal tip.
 10. The method of claim 7, further comprising: removinga portion of the fixation device in-situ, the removed portion of thefixation device including the blind hole.
 11. A method, comprising:inserting a k-wire through a first bone and through a second bone suchthat a portion of the k-wire extends from a surface of the second bone;sliding a blind hole of a fixation device over the end of the k-wire;driving the fixation device into the second bone and the first bonealong an axis defined by the k-wire, a bottom wall of the blind holecontacting the end of the k-wire as the fixation device is driven intothe bone; and removing the k-wire from the blind hole.
 12. The method ofclaim 11, wherein driving the fixation device includes rotating thefixation device using a driving tool.
 13. The method of claim 11,wherein the first bone is a talus and the second bone is a calcaneus.14. The method of claim 11, wherein the first bone is a tibia and thesecond bone is a fibula.
 15. The method of claim 11, wherein thefixation device includes an elongate body extending from a distal end toa proximal end, the distal end defining the blind hole extending to adepth from a distal tip.
 16. The method of claim 15, wherein thefixation device further includes a head disposed at the proximal end ofthe elongate body, the head having a diameter greater than an externaldiameter of the elongate body.